Astellas and Medivation announced that the Food and Drug Administration has approved a new indication for Xtandi (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

Xtandi is an oral androgen receptor inhibitor already approved for patients with metastatic CRPC who have previously received docetaxel. This new approval is based on priority review of the supplemental New Drug Application (sNDA) comprised of results from the Phase 3 PREVAIL trial.

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Results of the PREVAIL trial showed that men receiving Xtandi and GnRH therapy exhibited a statistically significant improvement in both overall survival an delayed time to radiographic progression (83%, HR=0.17; P<0.0001) or death (29%, HR=0.71; P<0.0001) as compared to those on placebo and GnRH therapy. Xtandi also delayed time to initiation of chemotherapy and time to a skeletal related event.

Xtandi is available in 40mg strength capsules in 120-count bottles.

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